GUEST CONTRIBUTORS

  • 5 Best Practices MSD Regulatory Affairs Used To Implement Strategic Sourcing Partnerships
    5 Best Practices MSD Regulatory Affairs Used To Implement Strategic Sourcing Partnerships

    In order to effectively extend the capacity of its organization using external partners, Merck & Co., Inc. decided to shift from limited, tactical, piecemeal outsourcing to a strategic outsourcing model. This article summarizes the first five of 10 key elements — or best practices — that were critical for the successful implementation of its strategic partnerships.

  • Will CDMOs Commit To Fully Transparent Audits?
    Will CDMOs Commit To Fully Transparent Audits?

    The first two articles in this series discussed the physical elements of facility design that sponsors look for in their contract development and manufacturing organizations (CDMOs) and sponsor requirements for dedicating equipment to GMP operations, equipment redundancy, and immediate disclosure of equipment and facility issues. This article presents solutions to improve transparency during sponsor audits of CDMOs.

  • Key Takeaways From The FDA’s New Continuous Manufacturing Guidance
    Key Takeaways From The FDA’s New Continuous Manufacturing Guidance

    The FDA recently issued a draft guidance entitled “Quality Considerations for Continuous Manufacturing” in an effort to advance greater predictability for companies adopting CM technology. Specifically, the FDA hopes this draft guidance will support the development and adoption of CM for brand, generic, and over-the-counter drugs.

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PHARMA OUTSOURCING WHITE PAPERS

BsAbs: Save Time With One-Step Purification BsAbs: Save Time With One-Step Purification

Bispecific antibodies (BsAb) can, in early screening phases, be purified using protein A chromatography in a single step. In this study, BsAb constructs were efficiently purified using a one-step approach, saving 4 to 6 weeks.

What Clinical Teams Should Know About Changing Trial Logistics What Clinical Teams Should Know About Changing Trial Logistics

When it comes to clinical supplies, the journey is every bit as important as the destination and the price of failure is high. This paper discusses how supply logistics are changing and contains examples of how Fisher Clinical Services is deploying flexible solutions to ensure secure, efficient and cost-effective passage of clinical supplies.

Efficient Cleaning-In-Place Methods For Protein-Based Antibody Affinity Chromatography Resins

This whitepaper discusses cleaning of affinity resins intended for use in the purification of monoclonal antibodies and antibody fragments.

Towards A Unified Process Development Strategy For Batch And Continuous Chromatography

Here we describe a process development methodology that enables design of either a batch or a continuous chromatography step based on the same set of experimental data.

BsAbs: Save Time With One-Step Purification

Bispecific antibodies (BsAb) can, in early screening phases, be purified using protein A chromatography in a single step. In this study, BsAb constructs were efficiently purified using a one-step approach, saving 4 to 6 weeks.

Optimizing Process Efficiency In Upstream Manufacturing

Increasing the integration of upstream and downstream processing and moving toward increased automation results in greater optimization of process efficiency - a key goal for biopharmaceutical production.

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PHARMA OUTSOURCING APP NOTES & CASE STUDIES

Drug Development: Take The Guesswork Out Of Crystallization

Batch-to-batch variability during the crystallization of active pharmaceutical ingredients (API) can have a profound impact on both safety and efficacy of the final drug formulation, and direct business and cost  implications for both the API manufacturer and downstream drug-formulation partners.

Fujifilm Diosynth Biotechnologies Drives Flexibility And Efficiency In Their Biomanufacturing Platform Using Integrated Automation

Through a successful implementation, Fujifilm was able to not only recognize the benefits an integrated automation platform offers but also the importance of working with an experienced partner.

Securing The Global Pharmaceutical Supply Chain Against The Threat Of Counterfeit Drugs

According to the World Health Organization (WHO), the prevalence of spurious, falsely-labelled, falsified, or counterfeit medicines, or SFFC medicines as they are known — medicines that are deliberately and fraudulently produced, packaged and/or mislabeled — is a growing trend worldwide which threatens both patient safety as well as public confidence in the health systems and regulatory bodies designed to provide oversight and control.

Efficient Cleaning-In-Place Methods For Protein-Based Antibody Affinity Chromatography Resins

This whitepaper discusses cleaning of affinity resins intended for use in the purification of monoclonal antibodies and antibody fragments.

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ABOUT US

Outsourced Pharma provides comprehensive analysis and exclusive content from thought leaders for the advancement of global outsourcing of drug development and manufacturing. We offer readers of our website and participants of our conferences – our Outsourced Pharma community – a deeper exploration and understanding of the relationships between pharmaceutical and biotechnology organizations with their service providers, and an open channel of communication.

About Outsourced Pharma Conferences
Outsourced Pharma Conference & Exhibition is a vibrant forum for thought-leadership and the application of best practices for professionals engaged in outsourcing drug development and manufacturing. These conferences and exhibitions form a community for networking and discussing topics most relevant to sponsor-provider partnerships and supply-chain management, within an open format that promotes panel and attendee interaction.

About OutsourcedPharma.com
OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.

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INDUSTRY INSIGHTS

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OUTSOURCING EVENTS

Developing a Part 11 Compliance Plan in Clinical Research March 26 - 26, 2019
1:00 PM - 2:30 PM EDT
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
Competency-Based Training in a GMP Environment – Results Based on Roles and Responsibilities March 27 - 27, 2019
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
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